Ethical and Legal Status of Adult and Competent Human Subjects Involved in Biomedical Research or Trials Cover Image

Etički i pravni položaj punoletnih poslovno sposobnih ljudi kao subjekata biomedicinskih istraživanja ili ogleda
Ethical and Legal Status of Adult and Competent Human Subjects Involved in Biomedical Research or Trials

Author(s): Vesna Klajn Tatić
Subject(s): International Law, Human Rights and Humanitarian Law, Health and medicine and law
Published by: Institut za uporedno pravo
Keywords: Biomedical research or trials; Adult and competent research subjects; Risks/ Benefits Analysis; Informed consent; Human genome; nondiscrimination; privacy; confidenatlity; genetic information;

Summary/Abstract: The aim of this article is to point out the most important issues of involving human subjects in biomedical research or trials, from both theoretical and professional point of view of people who works under rules, regulations, guidances and declarations of the national and international medical organizations and under current national laws in force. Firstly, it explains the term and the types of biomedical trials on human subjects. Secondly, examines the term of adult and competent research subjects in general. Furthermore, it analysis separately three major questions: risks and benefits of this kind of research and trials as first; informed consent of the subjects involved in such activities as second; status of research subjects involved in genetic research in the context of human rights as third.

  • Issue Year: 2010
  • Issue No: 2
  • Page Range: 209-236
  • Page Count: 28
  • Language: Serbian